China NMPA Product Recall - Disposable vacuum blood collection tubes
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Jiangsu Kangjian Medical Supplies Co., Ltd. is initiating a voluntary Class III recall for its disposable vacuum blood collection tubes. This action follows findings during a 2020 national medical device spot check, which identified non-compliance with established standards. Specifically, the products were found to have discrepancies in their nominal liquid capacity, graduation markings, and filling lines. The recall was reported by the company and published by the Jiangsu Provincial Drug Administration website on July 7, 2021, under the oversight of the National Medical Products Administration (NMPA). The affected products are identifiable by Registration Certificate Code Su Xie Zhu Zhun 20152411361. The company is required to provide detailed information regarding the specific models, specifications, and batches involved in the recall through a formal "Medical Device Recall Event Report Form." This voluntary recall ensures the removal of non-compliant medical devices from distribution to safeguard public health and maintain product quality standards set by regulatory authorities.
ID · 93a446b7-e856-4560-86d3-edea35790ef7